Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT06954831
Ultra-hypofractionated Whole Breast Irradiation With Lumpectomy Cavity Boost for the Treatment of Stage I-III Breast Cancer
A Phase 2 study testing Cone-Beam Computed Tomography, Hypofractionated External Beam Radiation Therapy and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 7 sites in United States.
Trial summary
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Cone-Beam Computed Tomography, Hypofractionated External Beam Radiation Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2025to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years
- Female
- Ability to read and understand English for questionnaires
- Histologically confirmed breast cancer
- Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
Show all 13Show fewer
- Patients must have undergone breast conserving surgery. Re-excision for negative margins is allowed
- Patients must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection)
- Must have at least one-high risk feature that would necessitate a lumpectomy cavity boost by the treating radiation oncologist
- Patient must have physician-reported "Excellent" or "Good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
- Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
- Clinically significant uncontrolled illness
- Stage IV breast cancer
- Diagnosis of Paget's disease of the nipple
- Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Pregnant or breastfeeding
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
City of Hope at Arcadia
Arcadia, California, 91007
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
- Not yet recruiting
City of Hope at Irvine Lennar
Irvine, California, 92618
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
- Recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
- Recruiting
City of Hope South Pasadena
South Pasadena, California, 91030
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
- Recruiting
City of Hope at South Bay
Torrance, California, 90503
Stephanie Yoon, MD, 626-359-8111, styoon@coh.org
- Recruiting
City of Hope Upland
Upland, California, 91786
Stephanie M. Yoon, 626-873-5241, styoon@coh.org
Stephanie M. Yoon
About this study
Official title: Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the impact of UF-WBI + CB as assessed by patient-reported Global Cosmesis Score (GCS) at 1 year.
SECONDARY OBJECTIVES:
- To characterize the patient-reported cosmetic appearance of the breast over time, as assessed by GCS.
II. To determine short- and long-term physician-reported cosmetic appearance of the breast, as assessed by GCS.
III. To evaluate the acute and late patient-reported radiation-associated toxicities.
IV. To evaluate the acute and late physician-reported radiation-associated toxicities.
- To estimate:
Va. 5-year in-breast recurrence; Vb. 5-year distant recurrence; Vc. 5-year disease-free survival (DFS); Vd. 5-year overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate patient-reported quality-of-life (QoL). II. To evaluate volumetric and dosimetric factors associated with acceptable breast cosmesis.
III. To evaluate volumetric and dosimetric factors associated with acute and late radiation-associated toxicities.
OUTLINE:
Patients undergo UF-WBI with CB once daily (QD) on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo cone-beam computed tomography (CBCT) prior to each radiation treatment.
After completion of study treatment, patients are followed up at 1 month, 6 months, then annually for up to 5 years.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma
- Being tested
- Cone-Beam Computed Tomography, Hypofractionated External Beam Radiation Therapy, Questionnaire Administration, Radiation Boost, Whole Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone-Beam Computed TomographyProcedure or surgery
Also called Cone Beam Computed Tomography, Cone Beam CT
Undergo CBCT
Hypofractionated External Beam Radiation TherapyRadiation
Undergo UF-WBI with CB
Questionnaire AdministrationOther
Ancillary studies
Radiation BoostRadiation
Also called BOOST, Boost Radiation, Boost Radiation Therapy, Boost Radiotherapy
Undergo UF-WBI with CB
Whole Breast IrradiationRadiation
Undergo UF-WBI with CB
| Study group | Role | What they receive |
|---|---|---|
| Treatment (UF-WBI with CB) | Experimental | Patients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment. Receives: Procedure: Cone-Beam Computed Tomography; Radiation: Hypofractionated External Beam Radiation Therapy; Other: Questionnaire Administration; Radiation: Radiation Boost; Radiation: Whole Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Responding patients are defined as patients with a rating of either "excellent" or "good" on the 4-point Global Cosmesis Score (GCS). Will be estimated along with the 95% exact binomial confidence interval.
Measured: At 1 year
Secondary outcomes (12)
Patient-reported cosmetic outcome using GCS - Baseline
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided.
Measured: At baseline
Patient-reported cosmetic outcome using GCS - 6 months
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided.
Measured: At 6 months
Patient-reported cosmetic outcome using GCS - 1 year
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided.
Measured: At 1 year
Patient-reported cosmetic outcome using GCS - 2 years
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided.
Measured: At 2 years
Patient-reported cosmetic outcome using GCS - 3 years
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided.
Measured: At 3 years
Physician-reported cosmetic outcome using GCS
For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided.
Measured: At baseline, at 6 months and at years 1, 2, and 3
Patient-reported radiation-associated toxicities
Will be assessed and graded using Patient-Reported Outcome Common Terminology Criteria for Adverse Events. Observed toxicities will be summarized by type, severity, and attribution. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided.
Measured: At 1 month, 6 months, and 1 year
Physician-reported radiation-associated toxicities
Will be assessed and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities will be summarized by type, severity, and attribution. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided.
Measured: At 1 month, 6 months, and years 1, 2, and 3
Incidence of in-breast disease recurrence
Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided.
Measured: Up to 5 years
Incidence of metastatic disease
Will be evaluated using RECIST criteria. For continuous variables, descriptive statistics such as number, mean, standard deviation, standard error, median (range) etc. will be provided. For categorical variables, counts and percentages will be provided.
Measured: Up to 5 years
Disease free survival
Will be estimated using the Kaplan-Meier method with Greenwood variance estimator and 95% confidence interval will be constructed based on log-log transformation.
Measured: From start of treatment to in-breast recurrence, metastatic disease, or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival
Will be estimated using the Kaplan-Meier method with Greenwood variance estimator and 95% confidence interval will be constructed based on log-log transformation.
Measured: From start of treatment to death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start28 Aug 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie M Yoon, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954831
- Sponsor's protocol ID
- 23860
- Other IDs
- NCI-2025-02185, 23860, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Ultra-Hypofractionated Whole Breast Irradiation With Concomitant Lumpectomy Cavity Boost
- ClinicalTrials.gov ID
- NCT06954831
- Acronym / sponsor ID
- 23860
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests how well ultra-hypofractionated (UF) whole breast irradiation (WBI) with lumpectomy cavity boost (CB) works in treating patients with stage I-III breast cancer. Breast conservation therapy (BCT) is the recommended treatment for patients with early stage breast cancer. BCT involves a lumpectomy followed by breast radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Traditionally, WBI has been given once daily over 5-6 weeks and then those at high-risk for recurrence receive additional radiation (boost) to the lumpectomy cavity daily over 4-8 days. This has now been replaced by moderate hypofractionated radiation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Although moderate hypofractionated radiation therapy reduces the length of treatment from 6-7 weeks to 3-4 weeks, the length of treatment still remains a barrier for many patients. UF-WBI with CB delivers radiation to the whole breast and the surgical cavity at the same time over 5 daily treatments. Giving UF-WBI with CB may prevent recurrence and prolong survival as well as improve the quality of life in patients with stage I-III breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the impact of UF-WBI + CB as assessed by patient-reported Global Cosmesis Score (GCS) at 1 year.
SECONDARY OBJECTIVES:
- To characterize the patient-reported cosmetic appearance of the breast over time, as assessed by GCS.
II. To determine short- and long-term physician-reported cosmetic appearance of the breast, as assessed by GCS.
III. To evaluate the acute and late patient-reported radiation-associated toxicities.
IV. To evaluate the acute and late physician-reported radiation-associated toxicities.
- To estimate:
Va. 5-year in-breast recurrence; Vb. 5-year distant recurrence; Vc. 5-year disease-free survival (DFS); Vd. 5-year overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate patient-reported quality-of-life (QoL). II. To evaluate volumetric and dosimetric factors associated with acceptable breast cosmesis.
III. To evaluate volumetric and dosimetric factors associated with acute and late radiation-associated toxicities.
OUTLINE:
Patients undergo UF-WBI with CB once daily (QD) on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo cone-beam computed tomography (CBCT) prior to each radiation treatment.
After completion of study treatment, patients are followed up at 1 month, 6 months, then annually for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (UF-WBI with CB) | Experimental | Procedure: Cone-Beam Computed Tomography, Radiation: Hypofractionated External Beam Radiation Therapy, Other: Questionnaire Administration, Radiation: Radiation Boost, Radiation: Whole Breast IrradiationPatients undergo UF-WBI with CB QD on consecutive business days for up to 5 fractions in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CBCT prior to each radiation treatment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years
- Female
- Ability to read and understand English for questionnaires
- Histologically confirmed breast cancer
Key exclusion criteria (8 listed)
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude breast irradiation
- Pathologically or clinically involved regional lymph nodes necessitating comprehensive regional nodal irradiation that includes the supraclavicular fossa
- Clinically significant uncontrolled illness
- Stage IV breast cancer
- Diagnosis of Paget's disease of the nipple
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone-Beam Computed TomographyAlso: Cone Beam Computed Tomography, Cone Beam CTUndergo CBCT | Procedure or surgery | Treatment (UF-WBI with CB) |
| Hypofractionated External Beam Radiation TherapyUndergo UF-WBI with CB | Radiation | Treatment (UF-WBI with CB) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (UF-WBI with CB) |
| Radiation BoostAlso: BOOST, Boost Radiation, Boost Radiation Therapy, Boost RadiotherapyUndergo UF-WBI with CB | Radiation | Treatment (UF-WBI with CB) |
| Whole Breast IrradiationUndergo UF-WBI with CB | Radiation | Treatment (UF-WBI with CB) |
Primary outcome
Response rate
Time frame: At 1 year
Responding patients are defined as patients with a rating of either "excellent" or "good" on the 4-point Global Cosmesis Score (GCS). Will be estimated along with the 95% exact binomial confidence interval.
12 secondary outcomes
Patient-reported cosmetic outcome using GCS - Baseline
Time frame: At baseline
Patient-reported cosmetic outcome using GCS - 6 months
Time frame: At 6 months
Patient-reported cosmetic outcome using GCS - 1 year
Time frame: At 1 year
Patient-reported cosmetic outcome using GCS - 2 years
Time frame: At 2 years
Patient-reported cosmetic outcome using GCS - 3 years
Time frame: At 3 years
Physician-reported cosmetic outcome using GCS
Time frame: At baseline, at 6 months and at years 1, 2, and 3
Patient-reported radiation-associated toxicities
Time frame: At 1 month, 6 months, and 1 year
Physician-reported radiation-associated toxicities
Time frame: At 1 month, 6 months, and years 1, 2, and 3
Incidence of in-breast disease recurrence
Time frame: Up to 5 years
Incidence of metastatic disease
Time frame: Up to 5 years
Disease free survival
Time frame: From start of treatment to in-breast recurrence, metastatic disease, or death from any cause, whichever occurs first, assessed up to 5 years
Overall survival
Time frame: From start of treatment to death from any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie M Yoon principal investigator
City of Hope Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cone-Beam Computed Tomography, Hypofractionated External Beam Radiation Therapy and Questionnaire Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.